FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel
in responding with consistency and accuracy to questions from the public on
subjects of current interest. Talk Papers are subject to change as more
information becomes available.
T99-28 Print Media: 301-827-6242
June 16, 1999
Consumer Inquiries: 888-INFO-FDA
NEW LABELING AND USE CHANGES FOR
REZULIN
Significant new changes are being made to the labeling
and recommended uses for Rezulin (troglitazone) - a drug used
to treat type 2 diabetes mellitus (non-insulin dependent
diabetes mellitus, or adult onset diabetes). These changes
are being made because new safety information (i.e., further
evidence of serious and sometimes fatal liver injury in
patients treated with Rezulin) indicates that the use of
Rezulin should be limited to patients not adequately
controlled by other therapy and should not be used as initial
single agent therapy in the treatment of type 2 diabetes. The
labeling changes also include recommendations for more
extensive monitoring of liver function in patients using
Rezulin. A patient information sheet has been added to the
labeling and will be available for distribution to patients by
pharmacists with each Rezulin prescription.
FDA and Parke-Davis agreed to these changes after careful
analyses of the drug's safety profile, drawing upon
clinical trials data, post-marketing surveillance data and the
recommendations made by FDA's Endocrinologic and Metabolic
Drugs Advisory Committee during a March 26, 1999
meeting. The new labeling and other measures being taken
regarding Rezulin are in keeping with the recommendations made
by that panel of outside experts.
Parke-Davis is issuing a nationwide letter to healthcare
professionals notifying them of these modifications. The
letter specifically notes that:
- Rezulin is no longer indicated to be used as initial
single agent therapy.
- Prospective Rezulin patients need to have liver
chemistries tested before starting therapy, then monthly
during the first year of therapy (rather than just 10
times previously recommended). After the first year of
therapy patients should be tested quarterly (rather than
"periodically" as previously recommended).
- Within the next few weeks, the company will prepare
a patient information sheet with FDA-approved
information about the safe and effective use of Rezulin.
This patient information sheet will be available for
distribution to patients by pharmacists with each
Rezulin prescription.
In addition to changes in labeling noted above, a new
indication will be added to Rezulin's labeling for its use in
combination with sulfonyureas and metformin in patients whose
diabetes is not adequately controlled by the combined use of
just these other diabetes drugs. This indication is based on
new clinical data evaluated by the agency.
FDA urges patients to consult with their physicians
before making any changes in their use of Rezulin. Any
adverse reactions associated with the drug should be reported
to the agency through MedWatch, FDA's adverse reaction
reporting system. Reports may be submitted to FDA by
telephone (800-332-1088), by fax (800-332-0178) or by mail to
MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20857.
Reports can also be filed via the internet at
www.fda.gov/medwatch. Reports may also be filed directly to
the manufacturer.
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